NDC 59228-104 Holy Water Mercy In A Bottle

Lidocaine Hcl, Benzalkonium Chloride

NDC Product Code 59228-104

NDC 59228-104-18

Package Description: 250 mL in 1 BOTTLE

NDC Product Information

Holy Water Mercy In A Bottle with NDC 59228-104 is a a human over the counter drug product labeled by Ems Contract Packaging. The generic name of Holy Water Mercy In A Bottle is lidocaine hcl, benzalkonium chloride. The product's dosage form is solution and is administered via topical form.

Labeler Name: Ems Contract Packaging

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.


Holy Water Mercy In A Bottle Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • BENZALKONIUM CHLORIDE .1 g/1000mL
  • LIDOCAINE HYDROCHLORIDE 4 g/1000mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • WATER (UNII: 059QF0KO0R)
  • EMU OIL (UNII: 344821WD61)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Ems Contract Packaging
Labeler Code: 59228
FDA Application Number: part348 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 04-25-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Holy Water Mercy In A Bottle Product Label Images

Holy Water Mercy In A Bottle Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredients

LIDOCAINE HCL   4%BENZALKONIUM CHLORIDE 50%  0.2%

Purpose

TOPICAL PAIN RELIEFANTISEPTIC

Indications & Usage

TOPICAL ANESTHETIC FOR USE DURING THE TATTOO PROCESS. PROMOTES FASTER HEALING, REDUCES REDNESS AND IRRITATION.

Warnings

FOR EXTERNAL USE ONLY.ASK A DOCTOR BEFORE USE IF YOU HAVE A CONDITION THAT COVERS A LARGE AREA OF THE BODY. WHEN USING THIS PRODUCT: AVOID CONTACT WITH EYES. IF CONTACT OCCURS RINSE EYES THOROUGHLY WITH WATER; DISCONTINUE USE IF EXCESSIVE INFLAMMATION OCCURS. IF CONDITION WORSENS OR DOES NOT IMPROVE WITH REGULAR USE AS DIRECTED, CONSULT A PHYSICIAN.

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED GET MEDICAL ATTENTION OR CONTACT THE POISON CONTROL CENTER IMMEDIATELY.

Caution

DO NOT FREEZE. STORE IN A COOL PLACE BELOW 77 DEGREES F (25 DEGREES C)

Directions:

SHAKE WELL PRIOR TO USE. CLEAN AREA. APPLY HOLY WATER GENEROUSLY AND AS NEEDED THROUGHOUT TATTOO PROCESS. EFFECTIVE ON OPEN SKIN ONLY.

Inactive Ingredients:

EMU OIL, PURIFIED WATER, PROPYLENE GLYCOL, ALOW VERA, FRAGRANCE

* Please review the disclaimer below.

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